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Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting

Primary Purpose

PONV

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
transcutaneous electrical acupoint stimulation
Sponsored by
Zhihong LU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PONV focused on measuring transcutaneous electrical acupoint stimulation, liver surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age ≥18 years
  • scheduled for elective liver surgery under general anesthesia

Exclusion Criteria:

  • body mass index less than 18 kg/m2 or higher than 30 kg/m2
  • American Society of Anesthesiologists status higher than Ⅲ
  • patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device
  • suspected or existed abuse of drug or alcohol
  • pregnant or breeding women
  • history of neurological or psychiatric disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    transcutaneous electrical acupoint stimulation

    Control

    Arm Description

    Outcomes

    Primary Outcome Measures

    incidence of nausea and vomiting by 24 hours after surgery

    Secondary Outcome Measures

    incidence of nausea and vomiting by 48 hours after surgery
    incidence of nausea and vomiting in PACU (post-anesthesia care unit)
    score of nausea and vomiting by 24 hours after surgery
    score of nausea and vomiting by 48 hours after surgery
    score of nausea and vomiting in PACU(post-anesthesia care unit)
    Quality of recovery score at 24 hours after surgery
    Quality of recovery score at 48 hours after surgery
    postoperative in-hospital stay
    death by 6 months after surgery

    Full Information

    First Posted
    May 25, 2022
    Last Updated
    May 25, 2022
    Sponsor
    Zhihong LU
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05396716
    Brief Title
    Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting
    Official Title
    Effect of Transcutaneous Electrical Acupoint Stimulation on Postoperative Nausea and Vomiting After Liver Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 30, 2022 (Anticipated)
    Primary Completion Date
    May 30, 2023 (Anticipated)
    Study Completion Date
    May 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Zhihong LU

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Incidence of postoperative nausea and vomiting (PONV) could be high as 60% after liver surgery. Acupoint stimulation has been proved to decrease PONV. In this study, we will investigate the effect of transcutaneous electrical acupoint stimulation on incidence of PONV after liver surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PONV
    Keywords
    transcutaneous electrical acupoint stimulation, liver surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    The stimulator is put in an opaque box
    Allocation
    Randomized
    Enrollment
    158 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    transcutaneous electrical acupoint stimulation
    Arm Type
    Experimental
    Arm Title
    Control
    Arm Type
    No Intervention
    Intervention Type
    Device
    Intervention Name(s)
    transcutaneous electrical acupoint stimulation
    Other Intervention Name(s)
    TEAS
    Intervention Description
    Electrodes are placed at acupoints and connected to the stimulator. Electrical stimulation is given during surgery.
    Primary Outcome Measure Information:
    Title
    incidence of nausea and vomiting by 24 hours after surgery
    Time Frame
    from end of surgery to 24 hours after surgery, in a total of 24 hours
    Secondary Outcome Measure Information:
    Title
    incidence of nausea and vomiting by 48 hours after surgery
    Time Frame
    from end of surgery to 48 hours after surgery, in a total of 48 hours
    Title
    incidence of nausea and vomiting in PACU (post-anesthesia care unit)
    Time Frame
    from end of surgery to discharge from PACU(post-anesthesia care unit), in an average of 30 minutes
    Title
    score of nausea and vomiting by 24 hours after surgery
    Time Frame
    from end of surgery to 24 hours after surgery, in a total of 24 hours
    Title
    score of nausea and vomiting by 48 hours after surgery
    Time Frame
    from end of surgery to 48 hours after surgery, in a total of 48 hours
    Title
    score of nausea and vomiting in PACU(post-anesthesia care unit)
    Time Frame
    from end of surgery to discharge from PACU, in an average of 30 minutes
    Title
    Quality of recovery score at 24 hours after surgery
    Time Frame
    from end of surgery to 24 hours after surgery, in a total of 24 hours
    Title
    Quality of recovery score at 48 hours after surgery
    Time Frame
    from end of surgery to 48 hours after surgery, in a total of 48 hours
    Title
    postoperative in-hospital stay
    Time Frame
    from end of surgery to discharge from hospital, in an average of 7 days
    Title
    death by 6 months after surgery
    Time Frame
    from end of surgery to 6 months after surgery, in a total of 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age ≥18 years scheduled for elective liver surgery under general anesthesia Exclusion Criteria: body mass index less than 18 kg/m2 or higher than 30 kg/m2 American Society of Anesthesiologists status higher than Ⅲ patients with contraindication to transcutaneous electrical stimulation, including skin damage, infection or implantable electrical device suspected or existed abuse of drug or alcohol pregnant or breeding women history of neurological or psychiatric disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhihong Lu
    Phone
    +8613891975018
    Email
    deerlu23@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shan He
    Phone
    8684775343
    Email
    1411950442@qq.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26522652
    Citation
    Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.
    Results Reference
    background

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    Acupoint Stimulation Alleviates Postoperative Nausea and Vomiting

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